Urogenital disorders affect a large number of women and can have profound effects on life quality. Although a number of treatments are available for some of the most serious gynecological and urinary tract diseases, many urogenital disorders are still poorly understood. As a consequence, treatments are often nonexistent, inefficient and/or invasive.
One example of a relatively rare, yet highly debilitating, urogenital disorder is vaginismus. Vaginismus results from the involuntary spasm of the pelvic muscles surrounding the outer third of the vagina, and interferes with a woman's ability to have a sexual relationship. This disorder is a major cause of unconsummated marriage, and can result in marked distress, interpersonal difficulty, and infertility. In addition, women suffering from vaginismus are sometimes unable to undergo a routine gynecological exam. Typical treatments of vaginismus include, for example, psychological therapy, Kegel exercises, and the use of a plastic dilator to progressively stretch the contracted muscles of the vagina. Although often effective, these treatments are time-consuming and cause high levels of anxiety.
Dyspareunia is also characterized by difficult or painful sexual intercourse, although, unlike with vaginismus, vaginal penetration is possible. Only symptomatic treatments, such as the use of lubricants, are typically employed.
Another poorly understood disorder is vulvodynia, which involves a number of syndromes, including vulvar vestibulitis, which is characterized by pain in the vulvar area. Women with vulvodynia may even experience discomfort from clothing such as tight jeans. Furthermore, vulvodynia also affects a woman's ability to have sexual intercourse. To date, only treatments that alleviate the symptoms of vulvodynia are available.
Interstitial cystitis is a complex, chronic disorder characterized by an inflamed or irritated bladder wall. An estimated 700,000 people have interstitial cystitis, and about 90 percent of them are women. Interstitial cystitis can severely affect life quality, as patients suffer from bladder pain, frequency and/or urgency of urination. People with severe cases of interstitial cystitis may urinate as many as 60 times a day. Also, people with interstitial cystitis often experience pain during sexual intercourse. Only treatments that alleviate the symptoms of interstitial cystitis are available. These treatments are often ineffective, invasive and recurrence of the symptoms is frequently observed.
Female sexual arousal disorder (FSAD) is the persistent and recurring inability to attain or maintain sufficient sexual excitement, or a lack of genital lubrication, swelling or other somatic response (Berman, et al., “Anatomy and Physiology of Female Sexual Function and Dysfunction,” Eur. Urol., 2000, 38:20–29). FSAD has been reported to have an overall prevalence of 14% in U.S. (Laumann, et al., Sexual Function in U.S., JAMA, 281:537–544 (1999)). Symptoms commonly associated with FSAD include: lack of or diminished vaginal lubrication, decreased clitoral and labial sensation and engorgement, and lack of vaginal smooth muscle relaxation. FSAD can occur secondarily to psychological disorders, but often is associated with medical or physiological changes. Currently, the only approved treatment for FSAD is a device called EORS, a vacuum pump device that induces clitoral engorgement. Sildenafil (i.e., Viagra®) has demonstrated efficacy in women with spinal cord injury, and in women using antidepressants such as serotonin reuptake inhibitors. However, it failed to show efficacy in a larger clinical trial including other patients suffering from FSAD. Phentolamine and testosterone have been used to treat FSAD, but these treatments may not effectively treat all of the symptoms associated with FSAD, and can be accompanied by significant side effects. An effective medical treatment is in need to treat this highly prevalent disorder.
Female sexual orgasmic disorder (FSOD) is defined as the persistent and recurrent difficulty, delay in or absence of attaining orgasm following sufficient sexual stimulation and arousal, and which causes personal distress. An effective medical treatment is in need to treat this highly prevalent disorder.
In view of the foregoing, it is readily apparent that there is a largely unmet medical need for effective, noninvasive and safe treatments of a large number of urogenital disorders including, but not limited to, vaginismus, dyspareunia, vulvodynia (including vulvar vestibulitis), interstitial cystitis, nonspecific urethritis (i.e., nonspecific pain and/or burning of the urinary tract), and sexual dysfunctions including, but not limited to, female sexual arousal disorders and female sexual orgasmic disorders. The present invention addresses these and other needs.